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RepoRting and leaRning systems foR medication eRRoRs: the Role of

phaRmacovigilance

centRes

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Reporting and

learning systems for medication errors:

the role of

pharmacovigilance

centres

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WHO Library Cataloguing-in-Publication Data

Reporting and learning systems for medication errors: the role of pharmacovigilance centres.

1.Medication Errors – prevention and control. 2.Pharmacovigilance.

3.Drug Monitoring. I.World Health Organization.

ISBN 978 92 4 150794 3 (NLM classification: QV 771)

© World Health Organization 2014

All rights reserved. Publications of the World Health Organization are available on the WHO website (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857;

e-mail: bookorders@who.int). Requests for permission to reproduce or translate WHO publica- tions – whether for sale or for non-commercial distribution – should be addressed to WHO Press through the WHO website (www.who.int/about/licensing/copyright_form/en/index.html).

The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization con- cerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent ap- proximate border lines for which there may not yet be full agreement.

The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of propri- etary products are distinguished by initial capital letters.

All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpreta- tion and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use.

The named authors alone are responsible for the views expressed in this publication.

Designed by minimum graphics

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iii

Contents

Foreword vii

Acknowledgements viii

Abbreviations ix

1. Objectives 1

2. Burden of medication errors on public health 2

2.1 Patient safety incidents 2

2.2 Medication incidents 2

2.3 Examples of medication error incidents 3

2.3.1 Prescribing error 3

2.3.2 Dispensing error 3

2.3.3 Medicine preparation error 5

2.3.4 Administration error 6

2.3.5 Monitoring error 6

2.4 Root causes of medication errors 6

2.5 Medication error reporting and learning systems 7 3. Organizations involved in medication error prevention 9

3.1 International level 9

3.1.1 World Health Organization 9

3.1.2 The World Alliance for Patient Safety 10 3.1.3 International Medication Safety Network 11

3.2 National level 12

3.2.1 Patient safety organizations 12

3.2.2 National pharmacovigilance centres 12

3.2.3 Poison control centres 14

3.3 Local level 15

3.3.1 Hospitals 15

3.3.2 Consumer and patient organizations 15

4. Terminology and definitions 19

4.1 Harmonization of terminology and definitions 21

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5. Classification 23

5.1 The conceptual framework for ICPS 23

5.2 ICPS drafting principles 23

5.3 The ICPS data structure 24

5.3.1 Medication incidents subcategories of the ICPS 26

5.4 Medicines and IV fluids involved 26

5.5 ICPS terms and pharmacovigilance classification systems 26 6. Identifying and reporting medication errors 28 6.1 Identifying MEs through individual case safety reports 28 6.1.1 The yellow card and other individual case safety

reporting forms 28

6.1.2 The P method 31

6.2 Detecting medication errors in practice 34

6.2.1 Incident reports 34

6.2.2 Patient chart review 34

6.2.3 Direct observations 34

6.2.4 Interventions by pharmacist 35

6.2.5 Adverse drug event trigger tools 35

6.2.6 Comparison of methods 36

6.3 Reporting medication errors 36

7. Analysing medication error incident reports 40 7.1 Summarizing and prioritizing medication error reports

(quantitative analysis) 40

7.1.1 Analysis by patient outcome 41

7.1.2 Analysis by medication process 41

7.1.3 Analysis by medication problem 41

7.1.4 Analysis by therapeutic group or medicine 41 7.2 Root cause analysis (qualitative analysis) 42 7.2.1 Human error and human factors and systems 46 7.2.2 System barriers to prevent medication errors 47 7.2.3 Identifying contributory factors to medication error incidents 48

7.2.4 Identifying root causes 50

7.2.5 Example of medication error report analysis form 51

7.2.6 Full root cause analysis 51

7.3 Summary 51

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8. Medication error prevention strategies 57

8.1 Country strategy for managing MEs 57

8.1.1 Basic steps to develop a national organization dedicated

to safe medication practice 57

8.1.2 Practical methods to minimize harm from medication errors 58

8.1.3 Preventing medication errors 58

8.1.4 Making them visible 58

8.1.5 Mitigating their effect when they occur 59 8.1.6 Raising awareness, education and training 59 8.2 Prevention strategies for medicine regulators and industry 61 8.2.1 The design of labelling and packaging of medicine products 61

8.2.2 Medicine names 65

8.2.3 Technical information on a medicine product 66 8.2.4 Formulation and presentation of medicine products 69

8.2.5 Risk management plans 70

8.3 Prevention strategies for reducing incidents with medical devices 72 8.3.1 Examples of strategies for the prevention of medical

devices medication error 73

8.4 Prevention strategies for individual practitioners 75 8.4.1 Examples of strategies for the prevention of medication

errors involving actions for health-care practitioners 76 8.5 Prevention strategies for health-care provider organizations 77

8.5.1 Examples of medication error prevention strategies for

health-care provider organizations 78

8.6 Prevention strategies for patients and carers 78 8.6.1 Examples of strategies for prevention of medication errors

for patients and carers 79

8.7 Summary 80

9. Collaborations 86

9.1 First level of partnership 86

9.2 Second level of partnership 87

9.3 Third level of partnership 87

9.4 Fourth level of partnership 88

9.5 Collaboration between the four levels of partnership 88

Annex 1: Glossary 89

contents

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vii

Foreword

This publication has been developed as part of the “Monitoring Medicines”

project (http://www.monitoringmedicines.org/) funded by the Research Directorate of the European Union under its Seventh Framework Programme.

It aims to enable readers to learn more about why adverse events occur with medicines, and what can be done to reduce patient deaths and negative health impacts arising from undetected problems with medicines safety globally. It provides a framework for advancing the application, coordination and optimal use of pharmacovigilance evidence, sharing that evidence and strengthening the links between national pharmacovigilance centres and other patient safety networks, to prevent medicines-related adverse events. The publication is expected to:

• increase the capacity of national pharmacovigilance centres to analyse reports of medication errors;

• increase the capacity of national pharmacovigilance centres to identify preventable medication errors; and

• support action to minimize the occurrence of preventable medication errors.

Representatives from the National Pharmacovigilance Centre, Morocco;

the National Patient Safety Agency, England; World Health Organization (Department of Essential Medicines and Health Products, Switzerland) and the Uppsala Monitoring Centre (Sweden) were the key partners engaged in this part of the Monitoring Medicines project.

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Acknowledgements

The first draft of the publication was prepared by Rachida Soulaymani Bencheikh (Morocco), David Cousins (England), Ghita Benabdallah (Mo- rocco), Raja Benkirane (Morocco) and Loubna Alj (Morocco). Sten Olsson (Sweden), Shanthi Pal (World Health Organization (WHO)) and David U (Institute for Safe Medication Practices, Canada) supported the development of subsequent versions.

Critical review and editorial suggestions on the content were provided by the following: Pia Caduff, Ennita Nilsson and Hanna Lindroos, all from Upp- sala Monitoring Centre, Annemarie Hellebek (Hvidovre Hospital, Denmark), Christina Fernandez and Mariano Madurga (Spanish Medicines Agency), Eliane Gil Rodrigues de Castro (CEATOX, São Paulo), Margaret Duguid (Australian Commission on Safety and Quality in Health Care), David Coulter (Consultant, New Zealand), Etienne Schmitt (La revue Prescrire, France), Desiree Kunac and Michael Tatley (Pharmacovigilance Centre, New Zealand), and Maria José Otero (Instituto para el Uso Seguro de los Medicamentos, Spain).

Staff from the national pharmacovigilance centres in Brazil, Islamic Republic of Iran, Italy, Republic of Moldova, Morocco, Nigeria, Spain, Switzerland, Thailand and Tunisia participated in the workshop on Medication Error in Morocco, in 2011, and provided technical case examples, feedback and com- ments on the document. The WHO Advisory Committee on Safety of Medic- inal Products was consulted throughout the development of this publication for advice and critical review. Philipp Lambach (WHO) reviewed the final document and provided useful input and suggestions.

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Abbreviations

The following abbreviations are used in this publication. For further explana- tions of terminology used, see the glossary.

ADE adverse drug event ADR adverse drug reaction

EU European Union

FMEA failure mode and effects analysis HCP health-care practitioner

ICPS International Classification for Patient Safety IMSN International Medication Safety Network ISMP Institute of Safe Medication Practice (USA) LASA look-alike, sound-alike

MAE medicine administration error

ME medication error

MERS medication error reporting system

NPSA National Patient Safety Agency (England) NRLS National Reporting and Learning System PCC poison control centre

PSO patient safety organization PVC pharmacovigilance centre RCA root cause analysis

UMC Uppsala Monitoring Centre (WHO Collaborating Centre for International Drug Monitoring)

WHO World Health Organization

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1. Objectives

This publication is intended to strengthen the capacity of national pharma- covigilance centres (PVCs) to identify, analyse and issue guidance to prevent or minimize medication errors (MEs) that harm patients. In addition it is in- tended to stimulate cooperation between national PVCs and patient safety or- ganizations (PSOs) to work together in order to minimize preventable harms from medicines.

Background and technical guidance are provided on the principles and meth- ods of ME incident reporting and learning. This information is intended to assist PVCs and PSOs to begin using the same philosophy, terminology and processes when undertaking this work.

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2. Burden of medication errors on public health

2.1 Patient safety incidents

Patient safety incident is a term used by PSOs when referring to an event or circumstance that could have resulted, or did result, in unnecessary harm to a patient.

Estimates show that in developed countries as many as one in 10 patients is harmed while receiving hospital care (Bates, 2010). The harm can be caused by a range of errors or adverse events. In developing countries, the probabil- ity of patients being harmed in hospitals is higher than it is in industrialized nations. The economic benefits of improving patient safety are compelling.

Studies show that additional hospitalization, litigation costs, infections ac- quired in hospitals, lost income, disability and medical expenses have cost some countries between US$ 6 billion and US$ 29 billion per year. Industries with a perceived higher risk, such as aviation and nuclear power plants, have a much better safety record than health care (World Alliance for Patient Safety).

2.2 Medication incidents

The term medication incident is used by PSOs when an adverse event is linked to the use of a medicine. A medication incident can be described as any unde- sirable experience that a patient has while taking a medicine, but which may not be related to the medicine.

Medication error (ME) is a commonly used term which has a similar mean- ing. The definition used in this document is “a failure in the treatment process that leads to, or has the potential to lead to, harm to the patient” (Ferner &

Aronson, 2006).

It is acknowledged that children are at the greatest risk for MEs. A systematic review of published research on MEs in children found, as with studies on adults, that the definition of ME was non-uniform across the studies (Miller et al., 2007).

The first studies on adverse drug events (ADEs) date back to 1984 with the Harvard Medical Practice Study. Of the 30 195 patients included, 19.4% ex- perienced an ADE and 17.7% of these ADEs were considered preventable.

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that harm or have the potential to harm patients when medicines are pre- scribed, supplied, dispensed, prepared, and administered clinically.

In the United States a list of high alert medicines and therapeutic groups of medicines has been developed based on error reports submitted to the Insti- tute for Safe Medication Practices (ISMP)’s National Medication Errors Re- porting Program, reports of harmful errors in the literature, and input from practitioners and safety experts (Institute for Safe Medicine Practices, 2012).

These medicines pose a higher risk of causing significant harm to patients when they are used in error. The clinical consequences resulting from an er- ror with these medicines are more likely to lead to fatal or serious harm. Ad- ditional safeguards should be included in practice to minimize errors with these medicines.

Box 1 ( page 4) illustrates the concept of high alert therapeutic groups. The list will change over time with the emergence of new therapeutic principles and others falling out of clinical practice.

Box 2 ( page 5) illustrates the concept of high alert medicines and is not ex- haustive. The list will change over time with the emergence of new medicines and others falling out of clinical practice.

2.3 Examples of medication error incidents 2.3.1 Prescribing error

Inappropriate starting dose of morphine tablets: A 70-year-old male pa- tient weighing 60 kg was prescribed slow-release oral morphine tablets, 60 mg twice a day, for arthritic pain. He had not been taking any opioid medicines. His previous analgesia medicine was oral tramadol tablets, 50 mg three times a day. After taking four doses of the oral morphine the patient was confused, hallucinating and drowsy. He was admitted to hospital where he remained for six days after receiving naloxone.

All doctors, both junior doctors and experienced senior doctors, commit pre- scribing errors; and the mean error rates can be as high as 8.9 per hundred medication orders (Dornan et al., 2009).

2.3.2 Dispensing error

Mis-selection of propranolol for prednisolone tablets: A 65-year-old female patient with a history of obstructive airways disease was seen by her general practitioner and prescribed an oral penicillin product and pred- nisolone, 40 mg daily for seven days. The community pharmacist mis- selected a 28-day patient pack of propranolol 40 mg tablets instead of prednisolone 5 mg tablets and labelled the pack of propranolol with a

2. BuRden of medication eRRoRs on puBlic health

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Box 1. High alert therapeutic groupsa

• Adrenergic agonists, intravenous (IV) (e.g. epinephrine, phenylephrine, norepinephrine)

• Adrenergic antagonists, IV (e.g. propranolol, metoprolol, labetalol)

• Anaesthetic agents, general, inhaled and IV (e.g. propofol, ketamine)

• Antiarrhythmics, IV (e.g. lidocaine, amiodarone)

• Antithrombotic agents, including:

— anticoagulants (e.g. warfarin, low-molecular-weight heparin, IV unfractionated heparin)

— factor Xa inhibitors (e.g. fondaparinux)

— direct thrombin inhibitors (e.g. argatroban, bivalirudin, dabigatran etexilate, lepirudin)

— thrombolytics (e.g. alteplase, reteplase, tenecteplase)

— glycoprotein IIb/IIIa inhibitors (e.g. eptifibatide)

• Cardioplegic solutions

• Chemotherapeutic agents, parenteral and oral

• Dextrose, hypertonic, 20% or greater

• Dialysis solutions, peritoneal and haemodialysis

• Epidural or intrathecal medications

• Hypoglycaemics, oral

• Inotropic medications, IV (e.g. digoxin, milrinone)

• Insulin, subcutaneous and IV

• Liposomal forms of drugs (e.g. liposomal amphotericin B) and conventional counterparts (e.g. amphotericin B desoxycholate)

• Moderate sedation agents, IV (e.g. dexmedetomidine, midazolam)

• Moderate sedation agents, oral, for children (e.g. chloral hydrate)

• Narcotics/opioids IV, transdermal, oral (including liquid concentrates, immediate and sustained-

• release formulations)

• Neuromuscular blocking agents (e.g. succinylcholine, rocuronium, vecuronium)

• Parenteral nutrition preparations

• Radiocontrast agents, IV

• Sterile water for injection, inhalation, and irrigation (excluding pour bottles) in containers of 100 mL or more

• Sodium chloride for injection, hypertonic, greater than 0.9% concentration

a Institute for Safe Medicine Practices (2012).

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dispensing label with instructions to take eight tablets daily. The same manufacturer supplied both the prednisolone and propranolol tablet packs and the labelling and packaging of the two products were very similar in appearance. The patient took the first dose and soon after- wards had difficulty breathing, became hypotensive and lost conscious- ness. She was rushed to hospital where she subsequently died.

A systematic review of research on dispensing errors found the incidence of such errors in community pharmacies ranged between 0.01% and 3.32%; in hospital pharmacies the figures were 0.02–2.7% (James et al., 2009). It is useful to report not only “unprevented” dispensing errors but also those dis- pensing errors that were in fact prevented from occurring. The latter serve as useful learning experiences and can form the basis for approaches that can be taken to prevent dispensing errors. A useful systematic review of prevented and unprevented error rates in different countries, was conducted by James et al. (2009) and includes data from Australia, Brazil, Denmark, Spain and the UK.

2.3.3 Medicine preparation error

Two male patients receiving treatment for multiple myeloma were pre- scribed intravenous amphotericin 5 mg/kg body weight as part of their anti-infective regimen. Two formulations of amphotericin were avail- able in the clinical area: amphotericin deoxycholate (Fungizone) and amphotericin as a lipid complex (Abelcet). The Fungizone formulation was prepared and then administered by clinical staff. The two patients

2. BuRden of medication eRRoRs on puBlic health

Box 2. High alert medicinesa

• Epoprostenol (Flolan), intravenous (IV)

• Magnesium sulfate injection

• Methotrexate, oral, non-oncologic use

• Opium tincture

• Oxytocin, IV

• Nitroprusside sodium for injection

• Potassium chloride for injection concentrate

• Potassium phosphates injection

• Promethazine, IV

• Vasopressin, IV or intraosseous

a Institute for Safe Medicine Practices (2012).

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subsequently died of amphotericin overdose. The maximum daily dose for Fungizone is 1.5 mg/kg.

2.3.4 Administration error

A patient was admitted following a traffic accident. He had sustained bilateral lower limb fractures, but was recovering well. Cardiac arrest followed with symptoms consistent with a large pulmonary embolus.

The patient was resuscitated long enough to enable him to be trans- ferred to a critical care unit, but died shortly afterwards despite intensi- fied treatment. On his drug chart, the prophylactic heparin injections were not signed as being administered on several occasions.

What constitutes a medicine administration error (MAE) varies from study to study making comparisons difficult. Some studies include time errors: for example, the medicine is given one hour earlier or later than it was prescribed for, while other studies ignore them. The focus of MAE research on the num- ber of errors can be misleading and may overestimate the problem. Many researchers consider the severity of the errors which are important from the patient’s perspective (Kelly & Wright, 2011).

2.3.5 Monitoring error

A 42-year-old male patient had an emergency admission to hospital with lithium toxicity. Unfortunately his blood lithium levels were out of date. The last level that had been recorded (5 months earlier) was within the therapeutic range; hence his oral lithium prescription was re-authorized. His two most recent outpatient appointments had been cancelled and his lithium levels were not being regularly monitored. At the time of reporting, the patient was being ventilated.

2.4 Root causes of medication errors

MEs include errors of omission as well as errors of commission. MEs, like other types of patient safety incidents, usually arise from human factors and poorly designed health-care products and systems rather than the individual performance of a single practitioner. This can be seen clearly if medication incident reports are collected together in an individual hospital or across a health-care system. Similar medication incidents occur involving different health-care staff. Disciplining one member of the health-care team involved in an ME does not prevent an identical error recurring. It is important to identify and address the root causes of errors to enable these risks to be mini- mized.

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Ensuring safe medication practice requires an understanding of human fac- tors (the reasons why humans make errors), and that health-care products and systems should be designed to minimize the risks of MEs harming patients.

Published research indicates that MEs occur frequently but that not all errors cause harm or have the potential to cause harm. It is important to understand what is meant by the terms ME, ADE and adverse drug reaction (ADR) when reviewing published literature (Morimoto et al., 2004).

2.5 Medication error reporting and learning systems

The most important knowledge in the field of patient safety is how to prevent harm to patients during treatment and care. The fundamental role of a patient safety reporting system is to enhance patient safety by learning from failures of the health-care system. Health-care errors are often provoked by weak sys- tems and often have common root causes which can be generalized and cor- rected. Although each event is unique, there are likely to be similarities and patterns in sources of risk which may otherwise go unnoticed if incidents are not reported and analysed.

The WHO draft guidelines for adverse event reporting and learning systems were published by the World Alliance for Patient Safety in 2005 to help countries develop or advance reporting and learning systems in order to improve the safety of patient care.

Reporting is fundamental to detecting patient safety problems. However, on its own it can never give a complete picture of all sources of risk and patient harm. The guidelines also suggest other sources of patient safety information that can be used both by health services and nationally.

Figures from the United Kingdom, one of the countries that is active in im- plementing ME reporting and learning systems may illustrate the level and type of reporting performance that can be achieved. Between January 2005 and December 2010, 517 415 medication incident reports were received from England and Wales, constituting about 10% of all patient safety incidents. Of the medication incidents 75% came from acute general hospitals, while small- er numbers, 8.5%, came from primary care. Some 16% of the medication incidents reported actual patient harm and 0.9% of these incidents resulted in death or severe harm. The process steps involved in the largest number of error reports were

• medicine administration, 50%;

• prescribing, 18%;

• omitted and delayed medicine, 16%; and

• wrong dose, 15% (Cousins et al., 2012).

2. BuRden of medication eRRoRs on puBlic health

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References

Bates D. (2010). Patient safety research introductory course Session 1. What is patient safety? Geneva: World Health Organization (http://www.who.int/

patientsafety/research/ps_online_course_session1_intro_2in1_english_2010_en.pdf, accessed 26 March 2014).

Cousins DH, Gerrett D, Warner B (2012). A review of medication incidents reported to the National Reporting and Learning System in England and Wales over six years (2005–2010). Br J Clin Pharm.74:597–604. doi: 10.1111/j.1365- 2125.2011.04166.x.

Dornan T, Ashcroft D, Heathfield H, Lewis P, Miles J, Taylor D, et al. (2009). An in depth investigation into causes of prescribing errors by foundation trainees in relation to their medical education. EQUIP study. General Medical Council (http://

www.gmc uk.org/about/research/research_commissioned_4.asp, accessed 26 March 2014).

Ferner RE, Aronson JK (2006). Clarification of terminology in medication errors:

definitions and classification. Drug Saf.29:1011–22.

Institute for Safe Medication Practices (2012). List of high alert medicines.

Horsham, Pennsylvania: Institute for Safe Medication Practices (http://www.ismp.

org/tools/highalertmedications.pdf, accessed 6 April 2014).

James LK, Barlow D, McArtney R, Hiom S, Roberts D, Whittlesea C (2009).

Incidence, type and causes of dispensing errors: a review of the literature. Int J Pharm Pract.17:9–30.

Kelly J, Wright D (2011). Medicine administration errors and their severity in secondary care older persons’ ward: a multi-centre observational study. J Clin Nurs.21:1806–15. doi:10.1111/j.1365-2702.2011.03760.x.

Miller MR, Robinson KA, Lubomski LH, Rinke ML, Pronovost PJ (2007).

Medication errors in paediatric care: a systematic review of epidemiology and an evaluation of evidence supporting reduction strategy recommendations. Qual Saf Health Care.16:116–26.

Morimoto T, Gandhi TK, Sger AC, Hsieh TC, Bates DW (2004). Adverse drug events and medication errors: detection and classification methods. Qual Saf Health Care.13:306–14.

World Alliance for Patient Safety. WHO draft guidelines for adverse event

reporting and learning systems: from information to action. Geneva: World Health Organization (www.who.int/patientsafety/implementation/reporting_and_learning/

en/, accessed 6 April 2014).

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3. Organizations involved in medication error prevention

Patient safety has been defined as “freedom from accidental injury in health care”. Patient safety is a serious global public health issue and many coun- tries are increasingly recognizing the importance of improving patient safety.

Health authorities ought to put systems in place to collect, analyse and prevent MEs, be it at the local, national or international level. This section aims to present the different models committed to patient safety.

3.1 International level 3.1.1 World Health Organization 3.1.1.1 The pharmacovigilance programme

As a consequence of the thalidomide tragedy, World Health Organization (WHO) created a collaborative system for international collection of indi- vidual reports of suspected ADRs in 1968. The system is based on nation- al pharmacovigilance centres (PVCs) collecting case reports, initially from health-care professionals, but later also from patients and marketing authori- zation holders, and submitting them to WHO. The network of national PVCs submitting individual case safety reports (ICSRs) to the WHO database, Vi- gibase, maintained by the Uppsala Monitoring Centre (UMC) in Sweden, has expanded from 10 participants originally to considerably more than 100.

One of the main objectives of establishing the global database was, and still is, to facilitate the identification of rare incidents of medicine-related problems in clinical practice that were not identified during the pre-marketing develop- ment phase of a medicine. Such early signals identified by national PVCs or UMC are shared between countries in the network. Initially the focus of this signal analysis process was on harm caused by the pharmacological proper- ties of medicines or hypersensitivity or idiosyncratic reactions experienced by patients. Over time it became evident that many of the recorded injuries to patients were due to failure of health-care systems and/or failure of health- care professionals to ensure that applicable instructions or guidelines for use of medicines were being followed. Quite often patient harm, as recorded in adverse reaction databases, can be linked to e.g. overdose, inappropriate route of administration or use of contraindicated medicine combinations. It has be- come evident that the WHO ICSR database, VigiBase™, which held 7.5 mil-

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lion case records in 2012, collected since it was set up in 1968, is also a rich source of information for the study of MEs.

Initially the WHO Adverse Reaction Terminology (WHO-ART) did not in- clude specific terms that allowed reporters to indicate that a medicine-related reaction might be due to an error, but over time more such terms have been included in the terminology. Currently a considerable number of ICSRs sub- mitted to VigiBase contain terms that indicate the adverse effect may be due to a ME; this also demonstrates that many national PVCs have become en- gaged in identifying MEs.

3.1.1.2 Patient safety

In 2002, the World Health Assembly (WHA) adopted a resolution on patient safety (Resolution WHA55-18; WHO, 2002) that significant enhancement of health system performance can be achieved in Member States by preventing adverse events in particular, and by improving patient safety and health-care quality in general. The Resolution recognized the need to promote patient safety as a fundamental principle of all health systems and urged Member States to pay the closest possible attention to the problem of patient safety, to establish and strengthen the science-based systems that are necessary for im- proving patient safety and the quality of health care, including the monitoring of medicines, medical equipment and technology.

An effective safety culture in health care will exhibit the following high-level attributes that health-care professionals strive to operationalize through the implementation of strong safety management systems:

• where all workers (including front-line staff, physicians and administra- tors) accept responsibility for the safety of themselves, their co-workers, patients and visitors;

• that prioritize safety above financial and operational goals;

• that encourage and reward the identification, communication, and resolu- tion of safety issues;

• that provide for organizational learning from accidents; and

• that provide appropriate resources, structure, and accountability to main- tain effective safety systems.

3.1.2 The World Alliance for Patient Safety

WHO’s World Alliance for Patient Safety was launched in October 2004, to confirm and endorse the objectives of the WHA Resolution (Resolution

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to introduce a concrete health policy designed to prevent patient harm. The Alliance focuses on assessing and understanding problems caused by unsafe care by producing guidelines on reporting and learning for patient safety, the International Classification for Patient Safety (ICPS) and by enhancing re- search for patient safety guidance.

• First challenge: clean care is safer care

• Second challenge: safe surgery saves lives

The Alliance is also promoting innovation and encouraging commitment through initiatives such as “Patients for Patient Safety” as well as launching the Safety Prize and building skills for patient safety worldwide.

The Alliance has developed a range of patient safety education and training materials including “A multi-professional patient safety curriculum guide”

with slides and workshop materials (WHO, 2011).

3.1.3 International Medication Safety Network

At the international level, studies have shown that collaboration is needed be- tween all parties dedicated to medication safety and patient safety (Bencheikh

& Benabdallah, 2009). In 2006, the International Medication Safety Network (IMSN) was founded with the following objectives:

• to avoid duplication of ME cases;

• to develop a common terminology; and

• to share and exchange cases of ME and prevention strategies so as to avoid making the same errors again.

The Network now includes members from more than 20 countries, independ- ent agencies, scientific societies, government agencies, associations, PVCs and the ISMP. The IMSN also focuses on the prevention of MEs and contrib- utes to safer health care by supporting dissemination and implementation of medication-related patient safety solutions. The Network is also supporting safe medication practice centres and effective collaboration between PVCs and safe medication practice centres by sharing data and knowledge to build up expertise. It serves WHO and national agencies as an expert stakeholder organization responding to patient safety initiatives.

The IMSN is hosted by The Institute of Safe Medication Practices, in Penn- sylvania, USA. The network operates as a cooperative of safe medication practice centres that operate reporting and learning systems for ME incidents.

The Network has an executive committee, a website (www.intmedsafe.net) and holds an international annual meeting.

3. oRganizations involved in medication eRRoR pRevention

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IMSN issued a position statement on pharmacovigilance and medication in 2009 (International Medication Safety Network, 2009).

3.2 National level

3.2.1 Patient safety organizations

Patient safety organizations (PSOs) undertake medication safety activities.

In the mid-nineteen-seventies the PVCs focused on collecting and detecting ADRs. It was at this time that PSOs were founded, at first to take charge of patient incidents occurring in hospitals, and later in all health-care communi- ties. Many, but not all, countries have PSOs.

In the USA, many agencies are dedicated to safe medication practice. These include the ISMP (ISMP, 1975) as well as the Joint Commission and Joint Commission International for Patient Safety, also designated as a WHO Col- laborating Centre for Patient Safety Solutions. The agency in the United Kingdom is the National Reporting and Learning Service (NRLS) (and pre- viously the National Patient Safety Agency). In Australia there is the Com- mission on Safety and a Health Care Quality Council.

PSOs undertake a range of activities to promote safer practice. These activi- ties may include the collection and analysis of ME reports, root cause analysis (RCA), development and promotion of prevention strategies and dissemina- tion of information leading to improvement of patient safety and a decrease in MEs (see also section 7.2). Prevention strategies and tools for health-care professionals can include training materials, seminars and e-learning. PSOs collaborate to share knowledge, expertise and prevention strategies. Examples of activities and products of some PSOs are shown in Table 1.

3.2.2 National pharmacovigilance centres

According to the WHO definition, pharmacovigilance is the science and ac- tivities related to the detection, assessment, understanding and prevention of adverse effects or any other medication-related problem (WHO, 2002). Since the outset, PVCs have been concerned with minimizing the risks of adverse reactions. Over the past forty years, pharmacovigilance has had an increas- ing focus on detecting and preventing MEs. It is possible to detect MEs from within the ICSRs that are received by national PVCs.

In 2006, WHO, UMC and the Moroccan National Pharmacovigilance Centre initiated a joint pilot project that systematically addressed aspects of this ex- tended function for a PVC; the project reviewed the collection and analysis of information on adverse events related to MEs. The pilot project demonstrated

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13

due to MEs, there were other PVCs that “inadvertently” collected this infor- mation, as ADR reports (Alj et al., 2007; Benkirane et al., 2009; Benabdallah et al., 2011). The project also investigated the presence of other systems for collecting ME reports in selected countries, and whether there was any col- laboration between these structures and the PVCs (see Table 2). The project led to the conclusion that it would be useful to develop a tool and a strategy to strengthen the capacity of PVCs to detect MEs from within ICSRs.

More recently the Monitoring Medicines project, with funds from the Euro- pean Commission, provided the opportunity to build on the first results of

3. oRganizations involved in medication eRRoR pRevention

Table 1. Examples of activities and products of some PSOs

Institute of Safe Medication Practice (ISMP) (USA)

National Reporting and Learning Service ( NRLS)/ National Patient

Safety Agency (NPSA) England Australia Patient safety brochure Patient safety toolkits and

e-learning Safety

Patient safety recommendations and implementation resources

Posters Seven steps to patient safety Improvement

National standardization, e.g. National Inpatient Medication chart Teleconferences Root cause analysis (RCA)

report writing tools and templates

Program for RCA

National standardization, e.g.

National Inpatient Medication Chart

Video conferences Design for Patient Safety:

medication topics E-learning programmes Medication safety pocket guide

Table 2. PVCs and PSOs: models and collaborations

Available models Percentage of respondents

n = 21

Countries with PVC, but no PSO 28.5

Countries with PVC and PSO 71.4

Collaboration between PVC and PSO 28.5

No collaboration between PVC and PSO 23.8

PVC plays the role of PSO 19.0

Source: Benabdallah et al. (2011).

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the pilot project. Based on the hypothesis that capturing comprehensive data (what, how and why) as a source of learning is the basis for identifying areas of change (Canadian Patient Safety Institute, 2006), the Monitoring Medicines project has focused on:

• developing useful tools, such as the P Method to detect preventable ADRs in national databases (see section 6.1.1);

• undertaking a retrospective analysis of ADRs in the pharmacovigilance databases of candidate PVCs, by applying the P method, to detect prevent- able ADRs;

• proposing improvements to existing ADR reporting forms to optimize ME detection;

• organizing training courses and seminars for health-care practitioners (HCPs) on the importance of reporting ADRs, and on the use of the P method to analyse ADRs.

The Monitoring Medicines project concluded that:

• Although primarily set up to collect and investigate ADR reports, the fields that are necessary for optimal capture of adverse events due to MEs either already exist in the PVCs’ ADR reporting forms, or can be easily added to the forms.

• Seminars and training courses should be organized to improve reporting of ADRs and MEs by HCPs.

• Special skills are needed and should be made available at the PVC for as- sessing the causal relationship between the medicine and the adverse reac- tion, and for assessing the preventability of an adverse event.

• Effective communication between PVC staff and HCPs, patients and PSOs is of paramount importance for collective learning to prevent MEs and to promote patient safety.

3.2.3 Poison control centres

There are few mechanisms for collecting data on MEs that exist and/or are managed outside hospital settings. Poison control centres (PCCs) remain an underutilized source of information on ADRs and MEs, and could help to detect and understand MEs. A Canadian study showed that one third of the calls (1525) to one Canadian Poison Centre about unintentional exposures in- volved medications (Ackroyd-Stolarz et al., 2011). Of those, 470 calls report- ed unintentional therapeutic errors and 61 ADRs. MEs represented 10.6% of

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drug poisoning cases reported to the Moroccan PCC. PCCs are better known to the public than PVCs, often operating around the clock, 7 days a week, and the staff are well trained, and may include physicians, pharmacists, nurses or other experts with training in toxicology, history taking and risk assessment.

PCCs have the advantage that they are contacted by telephone immediately after the event, and therefore, compared with PVCs, the information gathered by a PCC is more detailed and current, and often first-hand (reported by the patients themselves or by their families) (Volans et al., 2007).

Some PCCs carry out a systematic follow-up to learn of the outcome of the incident, and gather more information, if needed. When PCCs are staffed by physicians, they can provide immediate treatment advice. When the staff are not physicians (e.g. in Canada), they can have a consultation with a physician when it is needed (Ackroyd-Stolarz et al., 2011). It would be very useful to share data between PCCs and PVCs to optimize ME detection and to better understand the causes of MEs.

There are also many practical advantages of linking PVCs and PCCs. These include:

• sharing the same resources (administrative staff, communication material, databases, secretary, library, facilities, computer resources, personal com- petences, and laboratory support);

• sharing technical competencies in pharmacology and toxicology, causality assessment, regular updates on signals and alerts, epidemiology, statistics and communication.

3.3 Local level 3.3.1 Hospitals

Almost all hospitals have ME reporting systems. The most commonly used reporting methods are: incident report review, review of patient charts, direct observation, interventions by pharmacists and ADE trigger tools. For more detailed information, see section 6.2 (Detecting medication errors in prac- tice).

3.3.2 Consumer and patient organizations

Patient and consumer organizations are dedicated to patient or consumer welfare. Almost all countries have consumer and patient organizations. They may be active at the local or national level, but can also play a role at the in- ternational level. They generally target one kind of disease and focus on all

3. oRganizations involved in medication eRRoR pRevention

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aspects relating to it, leading to provision of help for patients in their daily life and improvement of their quality of life. Patients and consumers also need to be more involved in pharmacovigilance networks.

In recent years, the role of the patient in reporting ADRs has been increasing.

Several studies (van Grootheest et al., 2004; Mclernon et al., 2010; Krska et al., 2011; Mayor, 2011; van Hunssel et al., 2010, 2011) have shown the im- portance of patient reports, the quality of patient reports of ADRs and MEs, and the growing interest shown by patients in their drug therapy. Involving patients in pharmacovigilance is important because:

• patients are better informed about their conditions and treatment; and

• patients or their relatives will be the first to notice any observable problems resulting from the medication.

“Patients for patient safety” (PFPS), a programme of the WHO World Al- liance for Patient Safety, focuses on preventing MEs by educating patients about the concept of patient safety and by increasing patient awareness. This programme emphasizes the central role patients and consumers can play in efforts to improve the quality and safety of health care around the world.

PFPS works with a global network of patients, consumers, caregivers and consumer organizations to support patient involvement in the patient safety programmes of WHO Patient Safety.

Local patient and consumer organizations are a valuable resource for collect- ing data on ADRs and MEs in the local environment. They also organize workshops for educating patients on:

• awareness of ADRs and MEs

• the importance of the culture of patient safety

• the importance of the culture of patient engagement to provide safer care

• strengthening patient awareness about the importance of reporting ADRs and MEs

• effective communication about drug safety.

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References

Ackroyd-Stolarz SA, MacKinnon NJ, Murphy N, Gillespie E, Zed PJ (2011).

Adverse events related to medications identified by a Canadian poison centre. J Popul Ther Clin Pharmacol.18:e250-6. Epub 2011 May 2.

Alj L, Touzani MDW, Benkirane R, Edwards IR, Soulaymani R (2007). Detecting medication errors in pharmacovigilance database. Capacities and limits. Int J Risk Saf Med.19:187–94.

Benabdallah G, Benkirane R, Khattabi A, Edwards IR, Bencheikh RS (2011).

The involvement of pharmacovigilance centres in medication errors detection. A questionnaire-based analysis. Int J Risk Saf Med.23:17–29.

Bencheikh RS, Benabdallah G (2009). Medication errors: Pharmacovigilance centres in detection and prevention. Br J Clin Pharmacol.67:687–90.

Benkirane RR, Abouqal R, Haimeur CC, S Ech Cherif El Kettani SS, Azzouzi AA, Mdaghri Alaoui AA, et al. (2009). Incidence of adverse drug events and medication errors in intensive care units: a prospective multicenter study. J Patient Saf.5:16–22.

doi: 10.1097/PTS.0b013e3181990d51.

Canadian Patient Safety Institute (2006). Canadian root cause analysis framework – a tool for identifying and addressing the root causes of critical incidents in healthcare. Edmonton, Alberta.

International Medication Safety Network (2009). Position Paper on Pharmacovigilance and Medication Errors. Adverse drug reactions and

medication errors are two sides of the same coin: medication safety (http://www.

intmedsafe.net/IMSN/FCKuserfiles/file/IMSN_Position_Pharmacovigilance_

Copenhagen_2009%20(2).pdf, accessed 5 May 2014).

Krska J, Anderson C, Murphy E, Avery AJ (2011). How patient reporters identify adverse drug reactions: a qualitative study of reporting via the UK yellow card scheme. Drug Saf.34:429–36. doi: 10.2165/11589320-000000000-00000.

Mayor S (2011) UK patients’ reports of adverse reactions are more detailed than doctors’. BMJ.342:d3160.

McLernon DJ, Bond CM, Lee AJ, Watson MC, Hannaford PC, Fortnum H, et al.

on behalf of the Yellow Card Study Collaboration (2010). Adverse drug reaction reporting in UK. Drug Saf.33:775–88.

van Grootheest K, de Jong-van den Berg L (2004). Patients’ role in reporting adverse drug reactions. Expert Opin Drug Saf.3:363–8.

van Hunsel F, van der Welle C, Passier A, van Puijenbroek E, van Grootheest K (2010). Motives for reporting adverse drug reactions by patient-reporters in the Netherlands. Eur J Clin Pharmacol.66:1143–50. doi: 10.1007/s00228-010-0865-7.

3. oRganizations involved in medication eRRoR pRevention

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van Hunsel F, Talsma A, van Puijenbroek E, de Jong-van den Berg L, van Grootheest K (2011). The proportion of patient reports of suspected ADRs to signal detection in the Netherlands case–control study. Pharmacoepidemiol Drug Saf.20:286–91.

Volans GN, Karalliedde L, Wiseman H (2007). Poisons centres and the reporting of adverse drug events: the case for further development. Drug Saf.30:191–4.

WHO (2002). The importance of pharmacovigilance: safety monitoring of medicinal products. Geneva: World Health Organization.

WHO (2011). Patient safety curriculum guide (http://www.who.int/patientsafety/

education/curriculum/tools-download/en, accessed 3 June 2014).

Useful websites

World Alliance for Patient Safety (http://www.who.int/patientsafety/worldalliance/

en/, accessed 5 May 2014).

World Health Organization. Patient Safety (http://www.who.int/patientsafety/en/, accessed 5 May 2014).

World Health Organization. Patient safety campaigns (http://www.who.int/

patientsafety/campaigns/en/, accessed 5 May 2014).

World Health Organization. Patient Safety Education and Training. (http://www.

who.int/patientsafety/education/en/, accessed 5 May 2014).

World Health Organization. Reporting and learning for patient safety. (http://

www.who.int/patientsafety/implementation/reporting_and_learning/en/index.html, accessed 5 May 2014).

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4. Terminology and definitions

PVCs worldwide have been working with harmonized terms and tools that are developed, managed and maintained through the coordinated efforts of WHO and the UMC. Pharmacovigilance focuses on medication safety, with patient safety as its ultimate goal. The terms and definitions in pharmacovigi- lance have thus been “medicine centred”. On the other hand, in the field of patient safety, terminologies are applied in the context of improvement in the quality of health-care delivery systems. Medication safety is one aspect of pa- tient safety which bridges the patient safety and pharmacovigilance activities.

Terms and definitions need to evolve continuously to cover a widening frame- work and scope of work. Because the scope of pharmacovigilance has broad- ened to deal with MEs, some new terms belonging to the “patient safety”

aspect are now being used by PVCs; furthermore, some old terms in pharma- covigilance are being redefined to address its broadened scope. For example, according to its original definition, an ADR is “a response to a medicine which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease or for the modification of a physiological function”. But the widening scope of pharmacovigilance has led to a new definition being proposed for an ADR as “any noxious and unintended effect resulting not only from the authorized use of a medicinal product at normal doses, but also from medication errors and uses outside the terms of the marketing authorization, including the misuse and abuse of the medicinal product” (Yu, Nation & Dooley, 2005). This definition thus also includes MEs.

Medication safety is a broad and complex area within patient safety. Organi- zations (outside PVCs) that are involved in reporting MEs and/or are linked to networks such as IMSN (see section 3), use different terms and definitions in their work. In the past, such organizations worked separately from PVCs, with little communication or coordination. But since 2006, efforts have been made to bring the two together, thanks to the WHO pilot project on MEs and, more recently, the EC-funded Monitoring Medicines project (see sec- tion 3.2.3).

For a successful collaboration between the PVCs and other medication safe- ty organizations, there needs to be a common “language”, with harmonized

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terms and definitions. Yu and colleagues (2005) summarize the problems arising from the multiplicity of terms, their definitions and functional mean- ings. A comparison of some terms and how they are interpreted and used by PVCs and other medication safety organizations is shown in Table 3.

Table 3. Some terms and how they are interpreted and used by pharmaco­

vigilance centres (PVCs) and patient safety organizations (PSOs)a

Term Meaning in PVC Meaning in PSO Comment

Patient safety

incident Currently not used Event or circumstance which could have resulted, or did result, in unnecessary harm to a patient

PVCs could adopt this term

Medication

incident Currently not used Any undesirable experience that has happened to the patient while taking a drug but which may or may not be related to the drug

PVCs could adopt this term

Potential patient safety incident

Currently not used A patient safety incident

without harm Commonly referred to as

“near miss”

PVCs could adopt this term

Adverse event Any untoward medical occurrence temporally associated with the use of a medicinal product, but not necessarily causally related

An injury related to medical management, in contrast to complications of disease

PSO meaning not restricted to medicines

Adverse drug

event Currently not used Any injury resulting from medical interventions related to a drug

PVCs could adopt this term instead of “adverse event” (see section 4.1) Potential

adverse drug event

Currently not used No harm occurred even if error occurred or was intercepted

Commonly referred to as

“near miss”

Preventable adverse drug event

Currently not used Injury that is the result of an error at any stage of the medication use process.

= medication error PSOs could replace this term with “medication error”

(see below under

“medication error”)

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21 Non-preventable

adverse drug event

Currently not used Event that does not result from an error, but reflects the inherent risk of drugs and cannot be prevented given the current state of knowledge

= adverse drug reaction PSOs could replace this term with adverse drug reaction

Adverse drug

reaction (ADR) A response to a medicine which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease or for the modification of a physiological function

Any noxious effect resulting from the use of the medicinal product at normal doses within optimal conditions of use (non-preventable events)

Preventable

ADR Injury that is the result of an error at any stage of the medication use process

Currently not used = medication error This term was defined using a Delphi method by PVC and PSO representatives. PSOs could consider adopting the term

Medication

error A failure in the treatment process that leads to, or has the potential to lead to, harm to the patient

A preventable adverse

drug event Meaning essentially the same

PSOs could consider using this term instead of preventable adverse drug event (see above)

a These definitions reflect the current understanding of terms by representatives of PVCs and PSOs.

The definitions are expected to evolve with their broader use and adaptation and should be revisited at an appropriate time in the future.

4.1 Harmonization of terminology and definitions

Understanding and exchange of information between PVCs and PSOs at the local, national and international levels would improve if terms and definitions could be harmonized. A first attempt to reach consensus started with a Del- phi method, organized by the Moroccan PVC but the process needs to be strengthened and widened through the inclusion of other comments and sug- gestions. The group considered various terms including adverse event, adverse drug event, adverse drug reaction, medication error, potential adverse drug event, preventable adverse drug event and preventable adverse drug reaction.

4. teRminology and definitions

Table 3. Continued

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The first recommendation of the process was for PVCs to adopt the use of the term adverse drug event instead of adverse event (see Table 3) when referring to a medication-related event.

In conclusion, a critical factor for establishing efficient and standardized reporting systems between pharmacovigilance and PSOs is undoubtedly a common terminology.

Reference

Yu KH, Nation RL, Dooley MJ (2005). Multiplicity of medication safety terms, definitions and functional meanings: when is enough enough? Qual Saf Health Care.14:358–63.

Further reading

Bates DW, Boyle DL, Vander Vliet MB, Schneider J, Leape L (1995). Relationship between medication errors and adverse drug events. J Gen Intern Med.10:199–205.

European Union (2010). Directive 2010/84/EU of the European Parliament and of the council of 15 December 2010 (http://ec.europa.eu/health/files/eudralex/vol-1/

dir_2010_84/dir_2010_84_en.pdf, accessed 6 April 2014).

Ferner RE, Aronson JK (2006). Clarification of terminology in medication errors:

definitions and classification. Drug Saf.29:1011–22.

Hiatt HH, Barnes BA, Brennan TA, Laird NM, Lawthers AG, Leape LL, et al.

(1989). A study of medical injury and medical malpractice. An overview. N Engl J Med.321:480–4.

Morimoto T, Gandhi TK, Seger AC, Hsieh TC, Bates DW (2004). Adverse drug events and medication errors: detection and classification methods. Qual Saf Health Care.13:306–14.

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5. Classification

Patient safety is the reduction of risk of unnecessary harm associated with health care to an acceptable minimum. A patient safety incident is an event or circumstance that could have resulted, or did result, in unnecessary harm to a patient. The use of the term “unnecessary” in this definition recognizes that errors, violations, patient abuse and deliberately unsafe acts occurring in health care are unnecessary incidents, whereas certain forms of harm, such as an incision for a laparotomy are necessary (Runciman et al., 2009).

MEs are a subset of patient safety incidents. The same classification and anal- ysis systems used for other patient safety incidents should be used for ME reports. It is recommended that centres operating a system for reporting and learning from MEs should use the WHO International Classification for Pa- tient Safety (ICPS) (World Alliance for Patient Safety Drafting Group, 2009;

WHO/World Alliance for Patient Safety, 2009).

5.1 The conceptual framework for ICPS

The conceptual framework for the ICPS was designed to provide a much needed method of organizing patient safety data and information so that it can be aggregated and analysed to:

• compare patient safety data across disciplines, between organizations and across time and borders;

• examine the roles of system and human factors in patient safety;

• identify potential patient safety issues; and

• develop priorities and safety solutions (Donaldson, 2009).

5.2 ICPS drafting principles

The principles used for drafting the ICPS were as follows:

• The classification should be based upon concepts as opposed to terms or labels.

• The language used for the definitions of the concepts should be culturally and linguistically appropriate.

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• The concepts should be organized into meaningful and useful categories.

• The categories should be applicable to the full spectrum of health-care set- tings in developing, transitional and developed countries.

• The classification should be complementary to the WHO Family of International Classifications

(http://www.who.int/patientsafety/implementation/taxonomy/en/).

• The existing patient safety classifications should be used as the basis for developing the conceptual framework for international classifications.

• The conceptual framework should reflect a genuine convergence of inter- national perceptions of the main issues related to patient safety.

5.3 The ICPS data structure

Categories of characteristics of patient safety incidents include origin, discov- ery, reporting of the incident and the personnel involved, as well as when and where the incident occurred (see Figure 1).

Patient factor categories include demographics and the reason for the health- care encounter. The most important categories in the ICPS are contributory factors. By having sufficient information about the circumstances of an in- cident, these categories can be documented, and the greater understanding gained enables targeted actions to minimize the risk of similar incidents in the future.

Contributory factor categories include those concerning the patient, staff, work, organization and external factors. Mitigating factors are immediate ac- tions or circumstances which prevent or moderate the progression of an inci- dent towards harming a patient (Thompson et al., 2009).

Ameliorating actions take place after the incident has already caused harm to the patient. An example would be the resuscitation of a patient who has suf- fered a cardiac arrest as a result of inadvertent injection of high-concentration potassium chloride or treatment of a post-operative wound infection with an- tibiotics (Thompson et al., 2009).

An overview of the ICPS data structure is provided in Figure 1 (WHO World Alliance for Patient Safety, 2009). Note that several description headings have been added to the figure that were not included in the version proposed in 2009 (WHO World Alliance for Patient Safety 2009): “organizational and service factors,” “external factors”, “work and environmental factors” and

“staff and patient factors”.

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